BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2001097 · Received February 16, 2011

    Report

    Report Number
    1119421-2011-00126
    Event Type
    Other
    Date Received
    February 16, 2011
    Date of Event
    October 7, 2010
    Report Date
    January 17, 2011
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. CUSTOMER INDICATED THE USE OF AN APPROVED MONARCH (D) CARTRIDGE AND A BLUE HANDPIECE. ROOT CAUSE: NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. NO SAMPLE WAS RETURNED. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MGMT PERSONNEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 01/19/2011 AND 01/27/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 01/27/2011. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT HAS "1D INDUCED AGAINST-THE-RULE ASTIGMATISM THAT CANNOT BE CORRECTED SATISFACTORILY WITH GLASSES". THE SURGEON REPORTED THAT THE SURGERY WAS UNEVENTFUL AND THE IOL IS APPROPRIATELY ALIGNED. IN A F/U, THE SURGEON REPORTED THAT THE EVENT CONTINUES. SHE ALSO INDICATED THAT WHEN VISION IS CORRECTED WITH GLASSES, THE PT HAS "DISTORTION OF VISION AT ALL DISTANCES CONSTANTLY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AT5 10957890

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other I KNIFE| MONARCH DELIVERY SYSTEM| BSS| KERATOME| MPF LIDOCAINE| VISCOAT/PROVISC